Pharmacokinetic Study on the Administration of Nadroparin Dosing Serum HGF in Gynecological Patients

NCT01523652 | Completed

• 1 other identifier: FRFUnito60_07
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether HGF serum concentration might be raised in vivo by administering nadroparin given with prophylactic purpose to gynecological patients.

Conditions

Genital Diseases, Female; Ovarian Neoplasms; Urogenital Neoplasms

Outcome Measures

Primary Outcomes (1)

• AUC

  HGF serum concentration

  1 hour after nadroparin administration

Study Arms (2)

Nadroparin/control (phase 1)

patients affected by benign pelvic gynaecologic diseases were enrolled and treated with nadroparin for prophylactic anticoagulation; patients untreated with nadroparin were as control group.

Nadroparin (phase 2)

patients were enrolled among women planning gynaecological pelvic surgery and treated for 4 weeks with nadroparin for prophylactic anticoagulation. All these patients underwent laparotomy;

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic gynecological patients (benign diseases, oncological diseases)

You may qualify if:

• ≥ 18 years
• ECOG PS ≤ 1
• Neutrophils ≥ 1500 l -1, platelets ≥ 150,000 l -1, creatinine 0.6 to 1.2 mg dl -1, total bilirubin ≤ 1 mg dL -1, AST ≤ 35 U l-1, ALT ≤ 45 U l-1
• For patients in the study group: high-moderate risk of deep vein thrombosis (for the administration of LMWH for 30 days after surgery) under general anesthesia\> 30 minutes, laparoscopy + at least one risk factor (age\> 40 years, obesity, varicose veins, previous episode of deep vein thrombosis and / or pulmonary thromboembolism, thrombophilia, malignancy, prolonged immobility, congestive heart failure)

You may not qualify if:

• severe liver and renal disease
• diabetes
• hyperlipidemia
• marked osteoporosis
• HIV infection
• ongoing treatment with: immunosuppressive therapies, contraceptives, lipid-lowering drugs, NSAIDs, antiplatelet drugs, recent acute inflammatory or infectious (\<3 weeks)
• a history of allergies,
• drug possible confounding, caffeine, tobacco, ethanol (must not have been hired in the last 24 hours prior to sampling)
• high risk of bleeding: peptic ulcer, history of hemorrhagic stroke, or bleeding disorders, severe hypertension, cerebral aneurysms, arteriovenous malformations, brain metastases

Sponsors & Collaborators

• Azienda Ospedaliera San Giovanni Battista: lead
• University of Turin, Italy: collaborator

Study Sites (1)

ASO Ordine Mauriziano

Turin, Italy

Location

Related Publications (1)

• Surbone A, Fuso L, Passera R, Ferrero A, Marchese C, Martino C, Luchin A, Di Renzo MF, Zola P. Daily administration of low molecular weight heparin increases Hepatocyte Growth Factor serum levels in gynaecological patients: pharmacokinetic parameters and clinical implications. BMC Res Notes. 2012 Sep 23;5:517. doi: 10.1186/1756-0500-5-517.

  PMID: 22999213 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Genital Diseases, Female; Ovarian Neoplasms; Urogenital Neoplasms

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders; Male Urogenital Diseases

Study Officials

• Paolo Zola, MD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Paolo Zola

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: February 1, 2012
• Study Start: November 1, 2007
• Study Completion: November 1, 2008
• Last Updated: February 1, 2012

Record last verified: 2012-01

Locations

IT (1)